Background/Objectives: Since177Lu-DOTATATE was approved for patients with somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (NETs), tumor flare reactions including increased pain and small bowel obstruction (SBO) have been reported. Retrospective reviews report some success in using corticosteroids for treatment and prophylaxis of tumor flare reactions from177Lu-DOTATATE. Given that corticosteroids are used in practice to help prevent tumor flare reactions based on limited evidence, we aimed to assess if this practice was efficacious in our patient population. Methods: In this retrospective and single-institution study, we identified adult patients with NETs who were treated with177Lu-DOTATATE between 1 October 2019 and 31 December 2024; these patients received corticosteroids as prophylaxis for flare reactions due to high burden of disease, significant peritoneal or mesenteric disease, or disease involvement of critical structures as determined by the treating provider. Variables including demographics, diagnosis, treatment history, steroid dosing, and outcomes were collected within a RedCAP database. Results: Forty-six patients were identified as having received corticosteroid prophylaxis to prevent a tumor flare reaction due to177Lu-DOTATATE. Patients had a median age of 66, and 50% were female. The primary disease site was the small intestine (72%) followed by the pancreas (9%). The majority of patients had World Health Organization (WHO) grade 1 (41%) or WHO grade 2 (35%) diseases. Most patients (83%) received corticosteroids prior to the initiation of177Lu-DOTATATE, while 17% of patients received corticosteroids due to having a previous tumor flare after177Lu-DOTATATE administration. Despite corticosteroid prophylaxis, 28% of patients still experienced a tumor flare event, with three patients experiencing multiple tumor flare events. Small bowel obstructions occurred in 7% of patients and increased abdominal pain in 22% of patients. Adverse events (AEs) due to corticosteroids occurred in 28% of patients. Conclusions: Short-course corticosteroid prophylaxis to prevent tumor flare reactions in high-risk patients with neuroendocrine tumors treated with177Lu-DOTATATE did not appear to decrease the incidence of tumor flare reactions compared to previously reported numbers. Randomized, placebo-controlled trials looking at the use of corticosteroids to prevent tumor flare reactions in patients treated with177Lu-DOTATATE are needed to fully elucidate the safety and efficacy of corticosteroids used in this setting and to determine the impact on treatment outcomes.
背景/目的:自177Lu-DOTATATE获批用于生长抑素受体(SSTR)阳性胃肠胰神经内分泌肿瘤(NETs)患者以来,已有包括疼痛加剧和小肠梗阻(SBO)在内的肿瘤爆发反应的相关报道。回顾性研究显示,使用皮质类固醇治疗和预防177Lu-DOTATATE引起的肿瘤爆发反应取得了一定成效。鉴于目前临床实践中基于有限证据使用皮质类固醇来预防肿瘤爆发反应,本研究旨在评估该做法在我们患者群体中的有效性。方法:在这项回顾性单中心研究中,我们筛选了2019年10月1日至2024年12月31日期间接受177Lu-DOTATATE治疗的成年NETs患者;这些患者因疾病负荷高、存在显著腹膜或肠系膜病变、或经主治医生判定病变累及关键结构而接受皮质类固醇预防性治疗。通过RedCAP数据库收集人口统计学特征、诊断、治疗史、类固醇剂量及预后等变量。结果:共46例患者被确定为接受皮质类固醇预防177Lu-DOTATATE引起的肿瘤爆发反应。患者中位年龄66岁,50%为女性。原发部位主要为小肠(72%),其次为胰腺(9%)。大多数患者为世界卫生组织(WHO)1级(41%)或2级(35%)疾病。多数患者(83%)在开始177Lu-DOTATATE治疗前接受皮质类固醇预防,17%的患者因既往接受177Lu-DOTATATE后发生肿瘤爆发反应而使用皮质类固醇。尽管进行了皮质类固醇预防,仍有28%的患者发生肿瘤爆发事件,其中3例患者经历多次爆发。7%的患者出现小肠梗阻,22%的患者腹痛加剧。28%的患者出现皮质类固醇相关不良事件(AEs)。结论:与既往报道数据相比,短期皮质类固醇预防并未降低接受177Lu-DOTATATE治疗的高危神经内分泌肿瘤患者肿瘤爆发反应的发生率。需要进行随机安慰剂对照试验,以全面阐明皮质类固醇在此应用场景中的安全性和有效性,并评估其对治疗结局的影响。